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WO2018132835A1 - Outil chirurgical suivi à extension régulée - Google Patents

Outil chirurgical suivi à extension régulée Download PDF

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Publication number
WO2018132835A1
WO2018132835A1 PCT/US2018/013892 US2018013892W WO2018132835A1 WO 2018132835 A1 WO2018132835 A1 WO 2018132835A1 US 2018013892 W US2018013892 W US 2018013892W WO 2018132835 A1 WO2018132835 A1 WO 2018132835A1
Authority
WO
WIPO (PCT)
Prior art keywords
rotating tool
surgical
tool
hole
target bone
Prior art date
Application number
PCT/US2018/013892
Other languages
English (en)
Inventor
Constantinos Nikou
Branislav Jaramaz
David Davidson
Original Assignee
Smith & Nephew, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith & Nephew, Inc. filed Critical Smith & Nephew, Inc.
Priority to US16/478,314 priority Critical patent/US20190365391A1/en
Publication of WO2018132835A1 publication Critical patent/WO2018132835A1/fr
Priority to US16/751,911 priority patent/US20200155175A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1703—Guides or aligning means for drills, mills, pins or wires using imaging means, e.g. by X-rays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1626—Control means; Display units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1633—Sleeves, i.e. non-rotating parts surrounding the bit shaft, e.g. the sleeve forming a single unit with the bit shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1675—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00057—Light
    • A61B2017/00066—Light intensity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00203—Electrical control of surgical instruments with speech control or speech recognition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00212—Electrical control of surgical instruments using remote controls
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/107—Visualisation of planned trajectories or target regions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2055—Optical tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B2034/304—Surgical robots including a freely orientable platform, e.g. so called 'Stewart platforms'
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots

Definitions

  • the present disclosure relates generally to apparatus, methods, and systems for computer-aided orthopedic surgery. More specifically, the present disclosure relates to a controlled system for actuating tools to be used in computer-aided surgical procedures.
  • Cut guides or cutting blocks can be used in an orthopedic surgical procedure to assist a surgeon in cutting or modifying some portions of a target bone.
  • joint replacement surgeries such as total hip replacement (THR) or total knee replacement (TKR)
  • THR total hip replacement
  • TKR total knee replacement
  • the preparation of the bones can involve temporarily affixing saw guide cutting blocks to the bones so that a reciprocating saw blade can be held steady along its intended path. Placement of these blocks can be guided by manual instrumentation or through the use of jigs.
  • Existing surgical navigation systems typically use optical trackers to align guides, jigs, or couplers that interface with the jigs.
  • the use of such systems can provide surgeons with more information than traditional mechanical jigs.
  • the information can include range of motion capture, intraoperatively defined anatomical landmarks, and preoperatively defined anatomic landmarks.
  • Existing systems can align guides precisely, but interfacing trackers or couplers to guides or jigs for alignment purposes creates an extra unnecessary step.
  • Pilot holes can be created to help align guides, but the drilling of pilot holes with a handheld drill is challenging because surgeons may not be able to hold the drill at the proper angle and/or position before starting the drill. Additionally, it can difficult to advance a drill bit along the proper trajectory without having the drill bit move out of alignment with the preferred trajectory. Moreover, it is difficult to start a drill by hand without skipping or moving along a bone surface.
  • the system includes a tool assembly and a surgical system.
  • the tool assembly includes a rotating tool and a sleeve for holding the rotating tool, the sleeve including at least one anchoring feature configured to anchor the tool assembly to a target bone prior to actuation of the rotating tool.
  • the surgical system includes a navigation system configured to track at least a portion of the rotating tool and determine position information for the rotating tool, an alignment module configured to receive the position information and determine whether the rotating tool is in a proper position for drilling a hole into a target bone, a robotic control component configured to actuate and advance the rotating tool if the alignment module determines the rotating tool is in the proper position, and a monitor configured to determine if the rotating tool is advancing into the target bone along a predetermined path.
  • a navigation system configured to track at least a portion of the rotating tool and determine position information for the rotating tool
  • an alignment module configured to receive the position information and determine whether the rotating tool is in a proper position for drilling a hole into a target bone
  • a robotic control component configured to actuate and advance the rotating tool if the alignment module determines the rotating tool is in the proper position
  • a monitor configured to determine if the rotating tool is advancing into the target bone along a predetermined path.
  • the surgical system is configured to determine a surgical plan for the surgical procedure, determine at least one hole to be drilled into the target bone according to the surgical plan, and determine the predetermined path for the at least one hole to be drilled based upon the surgical plan.
  • the surgical plan defines a knee replacement procedure.
  • the system for includes a trigger configured to receive an input from a user and facilitate actuation of the rotating tool by the robotic control component.
  • the trigger includes at least one of a foot pedal operably connected to the surgical system, a vocal trigger operably connected to the surgical system, and a pushbutton integrated into the tool assembly.
  • the monitor is further configured to monitor alignment of the rotating tool during drilling of the hole and stop the rotating tool if the rotating tool is out of alignment.
  • the monitor is further configured to determine a depth of the rotating tool during drilling of the hole and stop the rotating tool when the rotating tool reaches a predetermined depth.
  • the rotating tool includes a tool tip for cutting the target bone during drilling of the hole.
  • the tool tip includes at least one of a drill bit and a cutting bur.
  • the sleeve comprises an elongated bore through which the rotating tool can extend from and be retracted into.
  • the sleeve is configured to position the rotating tool away from the target bone prior to actuation of the rotating tool.
  • the device includes a processing device operably connected to a computer readable medium configured to store one or more instructions. When executed, the instructions cause the processing device to track at least a portion of a rotating tool during the surgical procedure, determine position information for the rotating tool, determine, based upon the position information, whether the rotating tool is in a proper position for drilling a hole into a target bone such that at least a portion of the rotating tool is anchored to the target bone prior to actuation of the rotating tool, actuate and advance the rotating tool if the rotating tool is in the proper position, and determine if the rotating tool is advancing into the target bone along a predetermined path.
  • the one or more instructions comprise additional instructions that, when executed, cause the processing device to determine a surgical plan for the surgical procedure, determine at least one hole to be drilled into the target bone according to the surgical plan, and determine the predetermined path for the at least one hole to be drilled based upon the surgical plan.
  • the surgical plan defines a knee replacement procedure.
  • the one or more instructions comprise additional instructions that, when executed, cause the processing device to monitor alignment of the rotating tool during drilling of the hole and stop the rotating tool if the rotating tool is out of alignment.
  • the one or more instructions comprise additional instructions that, when executed, cause the processing device to determine a depth of the rotating tool during drilling of the hole and stop the rotating tool when the rotating tool reaches a predetermined depth.
  • the method includes tracking, by a navigation system operably connected to a surgical system, at least a portion of a rotating tool during the surgical procedure; determining, by the navigation system, position information for the rotating tool; receiving, by an alignment module operably connected to the navigation system, the position information; determining, by the alignment module, whether the rotating tool is in a proper position for drilling a hole into a target bone based upon the position information such that at least a portion of the rotating tool is anchored to the target bone prior to actuation of the rotating tool; actuating and advancing, by a robotic control component operably connected to the alignment module, the rotating tool if the rotating tool is in the proper position; and determining, by a monitor operably connected to the robotic control component, if the rotating tool is advancing into the target bone along a predetermined path.
  • the method further includes determining a surgical plan for the surgical procedure, determining at least one hole to be drilled into the target bone according to the surgical plan, and determining the predetermined path for the at least one hole to be drilled based upon the surgical plan.
  • the surgical plan defines a knee replacement procedure.
  • the method further includes monitoring alignment of the rotating tool during drilling of the hole and stopping the rotating tool if the rotating tool is out of alignment.
  • the method further includes determining a depth of the rotating tool during drilling of the hole and stopping the rotating tool when the rotating tool reaches a predetermined depth.
  • the example embodiments as described above can provide various advantages over prior techniques.
  • the techniques as taught herein can reduce the time spent mounting a cut guide onto a target bone.
  • the techniques also provide for more accurately drilling properly located and sized holes for pinning cut guides in the optimal position for a specific implant component.
  • FIG. 1 is a block diagram depicting a system for providing surgical navigation to ensure an orthopedic procedure is consistent with a surgical plan.
  • FIG. 2 is an illustration of an operating room with a system employing a navigated robotic surgical tool in accordance with certain embodiments of the invention.
  • FIG. 3 is a block diagram depicting a system implemented as one embodiment of the invention.
  • FIG. 4 is a cross sectional view in side elevation illustrating a portion of the system generally described in FIG. 3.
  • FIG. 5 is a cross sectional view in side elevation illustrating a portion of the system generally described in FIG. 3.
  • FIG. 6 is a block diagram depicting a system implemented as another embodiment of the invention.
  • FIG. 7 illustrates a perspective view of another embodiment of the invention.
  • FIG. 8 illustrates a process in accordance with an embodiment of the invention.
  • FIG. 9 illustrates an alternative process in accordance with certain embodiments of the invention.
  • This disclosure describes certain embodiments of navigated surgical systems and processes for determining when a tool is properly positioned and aligned on a work surface to allow for user-prompted initiation of the tool, such as for gradual extension of a drill bit along its axis.
  • numerous specific details are set forth in order to provide a thorough understanding of example embodiments. It will be evident to one skilled in the art, however, that embodiments can be practiced without these specific details.
  • the term "implant” is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure, either permanently or on a trial basis.
  • an implant in a knee replacement procedure, can be placed on one or both of the tibia and femur. While the term “implant” is generally considered to denote a man-made structure (as contrasted with a transplant), for the purposes of this specification, an implant can include a biological tissue or material transplanted to replace or enhance a biological structure.
  • the invention can be implemented in systems that are particularly adapted for implant surgery and, in particular, knee implant surgery.
  • the inside of a femoral knee implant typically includes three flat surfaces.
  • the end of the patient's femur can be prepared to receive the implant by cutting three planar surfaces at different angles that match the inside of the femoral implant. Typically, these cuts are made with a sagittal saw.
  • Preparation of the bone traditionally involves affixing cut guides to the bone to ensure each cut is made along the intended plane. The placement of these cut guides can be guided by manual instrumentation or by a surgical navigation system.
  • FIGS. 1 and 2 illustrate components of a surgical navigation system 100 for controlling cutting elements during a procedure to prepare one or more operative bones for placement of an implant, according to certain embodiments.
  • the surgical navigation system 100 can assist a surgeon in cutting or modifying some portions of a target bone.
  • the surgical navigation system 100 can be used to selectively and optimally cut portions of the ends of the target bones and replace those portions with endoprosthetic implants.
  • FIG. 1 illustrates components of a surgical navigation system 100 that can be configured to perform robotically-assisted surgical procedures.
  • the surgical navigation system 100 can assist a surgeon in performing certain surgical procedures, such as knee replacement revision surgery, but can also be used for procedures involving other joints including, for example, hip replacement surgeries.
  • the surgical navigation system 100 can include a computer system 110 to provide a display for viewing location data provided by optical trackers 112 as read by a position tracker 114.
  • the optical trackers 112 and position tracker 114 can provide data relevant to the precise location of the bones in the knee joint once their location is registered with the system 100.
  • the position tracker 114 can detect tracking spheres located on the optical trackers 112 in order to gather location data for a patient.
  • the optical trackers 112 can be arranged into an array having fixed dimensions known by the position tracker 114 and/or the surgical navigation system 100. By monitoring the movement of the optical trackers 112 in the workspace, as well as the relative distance between the individual optical trackers (e.g.
  • the surgical navigation system 100 can monitor and track the position and movement of the optical trackers throughout the workspace. From this, the surgical navigation system 100 can determine, for example, a position of an object such as a tool or a patient's bone that the optical trackers 112 are attached to.
  • the optical trackers 112 can be mounted such that information related to femur and tibia positions can be collected during a knee replacement procedure.
  • the position tracker 114 can be any suitable tracker, such as active trackers, passive trackers, optical trackers, electromagnetic trackers, infrared camera systems, or other similar systems.
  • FIG. 2 illustrates an exemplary optical surgical navigation setup.
  • Position tracker 114 and optical trackers 112 can be used to perform surgical navigation as described above.
  • the optical trackers 112 can be rigidly attached to any object (such as the surgical tool 116 or operative bones) that the surgeon wishes to track during the procedure.
  • the position tracker 114 can continuously monitor the workspace during the procedure.
  • the optical trackers 112 can be detected and tracked in workspace images collected by the position tracker 114. Using a known rigid spatial relationship of the optical trackers 112 to a surgical tool 116, the position of a surgical tool tip 118 in a three-dimensional space can be tracked by the position tracker 114 and continuously provided to the computer system 110.
  • the computer system 110 can continuously display the surgical tool 116 and/or the tip 118 location relative to the patient's anatomy.
  • the surgical tool 116 can be actuated when in an appropriate position according to a previously determined surgical plan.
  • FIG. 3 depicts a surgical navigation system, generally designated as 200, consistent with certain embodiments as described herein.
  • the surgical navigation system 200 can be operably connected to a surgical tool assembly 210 having a cleated sleeve 212 and a rotating tool 214.
  • the surgical navigation system 200 can be operably connected to the tool assembly via one or more wires.
  • the surgical navigation system 200 can include a tracking component similar to position tracker 114 as described above.
  • the tool assembly 210 can include a set of optical trackers configured to be tracked by the surgical navigation system 200, thereby providing the surgical navigation system with location information related to the current location of the tool assembly (and, by extension, the rotating tool 214).
  • the surgical navigation system 200 can determine position and orientation information for the tool assembly 210 based upon analysis of the location information.
  • the surgical navigation system 200 can determine the position and orientation (and resulting alignment) of the rotating tool 214 prior to operation of the rotating tool.
  • the surgical navigation system 200 can include a robotic control component 220 configured to control operation of the surgical tool assembly 210. It is to be appreciated that embodiments of the surgical navigation system 200 and/or the robotic control component 220 can be implemented by various types of operating environments, computer networks, platforms, frameworks, computer architectures, and/or computing devices.
  • the surgical navigation system 200 and/or the robotic control component 220 can include one or more processors and memory devices, as well as various input devices, output devices, communication interfaces, and/or other types of devices.
  • the surgical navigation system 200 and/or the robotic control component 220 can include a combination of hardware and software.
  • the surgical navigation system 200 and/or the robotic control component 220 can implement and utilize one or more program modules. Additionally or alternatively, the surgical navigation system 200 and/or the robotic control component 220 can implement and utilize one or more program modules or similar sets of instructions contained in a computer readable medium or memory (e.g., memory 204) for causing a processing device (e.g., processor 202) to perform one or more operations.
  • program modules include routines, programs, objects, components, data structures, etc., that perform particular tasks or implement particular abstract data types.
  • the surgical navigation system 200 and/or the robotic control component 220 can be implemented by one or more computing devices, including computers, PCs, server computers configured to provide various types of services and/or data stores in accordance with aspects of the described subject matter.
  • Exemplary server computers can include, without limitation: web servers, front end servers, application servers, database servers, domain controllers, domain name servers, directory servers, and/or other suitable computers.
  • Components of surgical navigation system 200 and/or the robotic control component 220 can be implemented by software, hardware, firmware or a combination thereof.
  • the surgical navigation system 200 can be implemented with a robotic- assisted bone preparation system, such as the total knee arthroplasty application that is implemented through the NAVIO® system.
  • NAVIO is a registered trademark of BLUE BELT TECHNOLOGIES, INC. of Pittsburgh, PA.
  • the surgical navigation system 200 can include other tracking systems, components, or modules.
  • the tool assembly 210 can include a cleated sleeve 212 that operates in conjunction with a rotating tool 214. In some implementations, the tool assembly 210 can be navigated and/or tracked through interaction with the surgical navigation system 200.
  • the surgical navigation system can include a trigger 224 configured to provide a manual control for initiating and stopping operation of the tool assembly 210.
  • the rotating tool 214 is a drill and the trigger 224 is a foot pedal.
  • the trigger 224 can be implemented as a vocal trigger configured to monitor for a voice command or another similar audible command for triggering operation of the rotating tool 214.
  • the trigger 224 is shown as a component of the surgical navigation system 200 by way of example only.
  • the trigger 224 can be integrated into the tool assembly 210.
  • the trigger 224 can be a pushbutton positioned on the base of the rotating tool 214, such as a cutting bur, such that the tool assembly 210 can be hand-operated by the surgeon.
  • the robotic control component 220 can include an alignment module 222 and a monitor 226.
  • the alignment module 222 can be configured to implement a crosshair interface 228.
  • the crosshair interface 228 can be configured to communicate with the monitor 226 to provide current location information for the rotating tool 214 during a surgical procedure (determined from, for example, the position and orientation information determined by the surgical navigation system 200 as described above).
  • the monitor 226 can analyze the location information to determine if the rotating tool 214 is correctly positioned and/or aligned.
  • the surgical navigation system 200 can provide a surgeon with information and/or instructions to align the rotating tool 214 with an intended operative location and trajectory before the rotating tool can be operated.
  • a display operably connected to the surgical navigation system 200 can display location and trajectory information to the physician as well as instructions or movement information for properly positioning and aligning the rotating tool 214.
  • the robotic control component 220 can be configured to communicate with the tool assembly 210 to advance the rotating tool 214 to a position that is adjacent to a work surface.
  • Known mechanisms for this advancement include lead screws, ball screws, linear actuators and worm gears.
  • the cleated sleeve 212 can be configured and positioned to hold the rotating tool 214 at a predetermined distance in relation to the work surface without actually touching the surface.
  • the rotating tool 214 can extend beyond the cleated sleeve 212 to ensure a proper starting position prior to operation of the rotating tool.
  • the surgical navigation system 200 can communicate tracking data to the monitor 226.
  • the monitor 226 can determine when the tool assembly 210 is in the proper alignment and location based upon the tracking data.
  • the rotating tool 214 can commence operation after it has been placed in the proper position for a predetermined length of time.
  • the surgical navigation system 200 can signal to the user that the rotating tool is in the correct position, but will not begin operation until the trigger 224 is actuated.
  • the robotic control component 220 can activate the tool assembly 210 to automatically rotate the rotating tool 214 and advance the rotating tool 214 linearly.
  • the alignment module 222 can monitor the alignment of the rotating tool and the monitor 228 can control the depth to which the rotating tool 214 penetrates a work surface within a workpiece (i.e., a drilling surface within a bone).
  • the robotic control component 220 can configure the trigger 224 to initiate movement of the rotating tool 214.
  • the rotating tool 214 can extend to move into contact with the work surface. In some embodiments, the rotating tool 214 does not begin rotating until it makes contact with the work surface.
  • the robotic control component 220 can implement the crosshair interface 228 for aligning the rotating tool 214 so that a cut or hole made by the rotating tool is consistent with a predetermined surgical plan.
  • the tool assembly 210 can further include adjustment means for making small adjustments to the position of the rotating tool 214.
  • the tool assembly 210 can include micro-servos or other small scale mechanical devices configured to adjust a position of the rotating tool 214 in response to an instruction from, for example, the robotic control component 220 and/or the alignment module 222.
  • the robotic control component 220 can track the position of the crosshair interface 228 to determine whether the rotating tool 214 has remained properly positioned and aligned during cutting.
  • the robotic control component 220 can overcome some of the limitations of conventional navigation systems when advancing the navigated or tracked rotating tool 214.
  • the robotic control component 220 configures and implements the monitor 226 to communicate with the crosshair interface 228 to ensure that the rotating tool 214 is properly aligned during a drilling operation or during another similar operation.
  • the monitor 226 can detect when the rotating tool 214 fails to maintain the proper alignment and can be configured to correct the alignment or to compensate for the misalignment.
  • the monitor 226 can also be configured to stop the robotic tool 214 when it fails to maintain the proper alignment.
  • the monitor 226 can be configured to retract the rotating tool 214 when it fails to maintain the proper alignment.
  • the surgical navigation system 200 can use the alignment module 222 to determine the location, depth, and alignment of any hole needed so that the cut guide can be attached to the bone in the correct place to enable the proper cuts to be made.
  • the surgical navigation system 200 provides for the easy alignment of cut guides that do not have to interface with manual instrumentation sets such as cut guide jigs. Such guides can be smaller or less intricate, which results in cost savings. Additionally, the invention provides a single system that can align multiple types of cut guides to support multiple surgeries and implant designs.
  • FIGS. 4 and 5 illustrate a cut-away illustration of the cleated sleeve 212 and rotating tool 214 in accordance with certain embodiments of the invention.
  • the cleated sleeve 212 can include an essentially cylindrical tubular sleeve 230 forming an elongated bore 232 through which the rotating tool 214 can extend.
  • a tip 234 can be biased in a slightly extended position beyond a mouth 236 of the bore 232 as illustrated in FIG. 4. Such an arrangement provides that the tip 234 can be pressed against the bone 240 while the rest of the tool assembly 210 is pivoted around that point until the alignment module 222 indicates the tool assembly 210 is aligned with the planned hole to be cut.
  • the rotating tool 214 can be retracted until the cleated sleeve 212 contacts the bone 240 to secure the position.
  • the retraction could be programmed to be a quick retraction, to minimize error in the alignment. If the tool assembly 210 remains aligned, the rotating tool 214 can be actuated to create the appropriate hole as is demonstrated by FIG. 5.
  • the cleated sleeve 212 can include a serrated edge configured to anchor the tool assembly 210 and/or the rotating tool 214 to the bone 240.
  • the cleated sleeve can provide an anchoring or engagement feature configured to stabilize and maintain the position of the tip 234 relative to the hole to be drilled into the bone 240, thereby reducing any potential movement of the rotating tool 214 or the tip when the tip contacts the bone.
  • the hole to be cut may be located on a sloped, curved, or otherwise angled portion of bone 240 where the tip 234 may be prone to sliding, skipping, or otherwise moving prior to engaging with the bone to cut the hole.
  • the cleated sleeve 212 can anchor the tool assembly 210 and/or the rotating tool 214 to the bone, thereby reducing or eliminating a chance of movement of the rotating tool when the tip 234 contacts the bone.
  • the tip 234 can be retracted into the bore 232 and the cleated sleeve 212 can be placed against the operative bone 240.
  • the crosshair interface 228 within the alignment module 222 can be used to ensure the position and alignment of the tool assembly 210 is correct.
  • the rotating tool 214 can begin to spin.
  • the robotic control component 220 can advance the rotating tool 214 until it hits the bone 240, thus reducing the chance that the tip 234 will be deflected from the intended location.
  • the monitor 226 can guide the rotating tool 214 to ensure that the rotating tool 214 follows a predetermined trajectory. This allows a surgeon to focus on controlling the trajectory, while the robotic control component 220 controls the depth and speed of the rotating tool 214.
  • FIG. 6 illustrates a standalone robotic system 300 in accordance with another embodiment of the invention.
  • the standalone robotic system 300 can control a surgical tool assembly, generally designated by the numeral 310.
  • the surgical tool assembly 310 is not connected to or otherwise controlled by a surgical navigation system, such as surgical navigation system 200.
  • the surgical tool assembly 310 can include a cleated sleeve 312 and a rotating tool 314.
  • the cleated sleeve 312 can be the same as or otherwise equivalent to the cleated sleeve 212 that is shown in FIGS. 3-5.
  • the rotating tool 314 can be any suitable rotating surgical tool, such as a drill, a bur, a screwdriver or other similar instrument.
  • the surgical tool assembly 310 can be implemented with a tracking system (not shown).
  • the standalone robotic system 300 can include an alignment module 316, a trigger 318, and a monitor 320 that function in a manner that is similar to the alignment module 222, the trigger 224, and the monitor 226 as shown in FIGS. 3-5 and described above.
  • the alignment module 316 can include a crosshair interface 322 that functions similarly to the crosshair interface 228 shown in FIGS. 3-5 and described above.
  • the alignment module 316 and the monitor 320 can be configured to control the depth of any holes produced by the rotating tool 314.
  • FIG. 7 illustrates a robotic tool assembly 400 in accordance with another embodiment of the invention.
  • the robotic tool assembly 400 can be configured to be used within a surgical navigation system, such as surgical navigation system 200 shown in FIGS. 3-5, or as a standalone system with a robotic control system, such as robotic control system 300 and surgical tool assembly 310, shown in FIG. 6.
  • the robotic tool assembly 400 can include a cleated sheath 410 encircling a tool holder 412 and a rotating tool 414. Similar to the above description of the cleated sleeve 212, in certain implementations the cleated sheath can include a serrated edge (as shown in FIG. 7) or another similar engagement or anchoring feature for anchoring the robotic tool assembly 400 to a target bone prior to operation of the rotating tool 414.
  • the tool holder 412 can be a collet and the rotating tool 414 can be a drill.
  • the rotating tool head 410 can be mounted on a platform 416 that includes a plurality of actuators 418 positioned between a proximal and a distal baseplate 422, 420 respectively.
  • the robotic tool assembly 400 can include six actuators 418.
  • the actuators 418 can be prismatic actuators, such as hydraulic jacks, or electric actuators, attached in pairs to three positions on the proximal baseplate 422.
  • the actuators 418 can be positioned to cross over to three mounting points on the distal baseplate 420. It should be noted that six actuators is described by way of example only, and additional numbers of actuators can be used. Similarly, the positioning and mounting of the actuators 418 as shown in FIG. 7 and described herein is by way of example only.
  • the arrangement of the actuators 418 and the baseplates 420-422 can allow the tool head 410 and the rotating tool 414 to be moved with six degrees of freedom.
  • the six degrees of freedom provide extra degrees of motion off-axis with the tool trajectory in order to possibly correct and/or compensate for the user deviating from a surgical plan.
  • the robotic tool assembly 400 can include a control box 424 and a power cord 426.
  • the control box 424 can include a control unit for controlling the actuators, a computer device, and/or an interface to an external computer system that can control the robotic tool assembly 400.
  • the power cord 426 can connect to an external power source.
  • certain embodiments of the robotic tool assembly 400 can be configured to automatically align the cutting tool 414 using the actuators 418.
  • the robotic tool assembly 400 can further be configured or otherwise instructed to perform the cutting or drilling autonomously.
  • a process 500 is described as a sample robotically controlled drilling process in accordance with aspects of the subject matter as described herein.
  • the process 500, or portions thereof, can be performed by or with the aid of one or more computing devices, a computer system, computer-executable instructions, software, hardware, firmware or a combination thereof in various embodiments.
  • portions of process 500 can be performed by a surgical navigation or a robotic system, such as surgical navigation system 200 shown in FIGS. 3-5, robotic system 300 shown in FIG. 6, robotic system 410 shown in FIG. 7, and/or other similar systems.
  • a rotating tool can be positioned 501 so that the tip is adjacent to a work surface where a cut is to be made according to a surgical plan.
  • the rotating tool can be the rotating tool 214 shown in FIGS. 3-5, the rotating tool 314 shown in FIG. 6, or the rotating tool 414 shown in FIG. 7.
  • the rotating tool can be a drill, a bur, or other similar tool or surgical instrument.
  • the work surface can be a bone or other similar work surface.
  • the rotating tool can be aligned 502 to provide for advancing the rotating tool tip along a predetermined path.
  • the rotating tool can be aligned using alignment module 222 shown in FIGS. 3-5 and/or alignment module 316 shown in FIG. 6.
  • the crosshair interface 228 of FIG. 3 or 322 is FIG. 6 is used.
  • the rotating tool can be activated 503 to advance the rotating tool tip outside of a cleated sleeve and toward the work surface.
  • the rotating tool can be activated by trigger 224 shown in FIGS. 3-5 or trigger 318 shown in FIG. 6.
  • the rotating tool can be activated by the robotic system after a surgeon waits a predetermined period of time with the tool in a proper alignment for a predetermined trajectory.
  • the rotating tool is not touching the work surface when it is activated and advances into the work surface when the alignment is correct.
  • a robotic system can monitor 504 whether the rotating tool is advancing along the predetermined path.
  • the movement of the rotating tool can be monitored with the monitor 226 shown in FIGS. 3-5 or the monitor 320 shown in FIG. 6. Once a depth is reached that is consistent with the surgical plan, the monitor ceases the operation of the rotating tool and can withdraw the rotating tool from the bone or work surface automatically or upon release of a trigger by the surgeon.
  • FIG. 9 illustrates a sample process for using a computer-assisted surgical (CAS) system, such as the surgical systems described above, for tracking and controlling the operation of a tool such as the rotating tool described herein.
  • the CAS system can receive 605 a surgical plan including, for example, information related to the surgical procedure such as surgery type (e.g., total knee replacement, partial knee replacement), implant family, implant size, optimal implant location, and other related information.
  • the CAS system can determine 610 one or more surgical components that are to be used during the procedure.
  • the one or more surgical components can include cut guides to be mounted to a patient's bone during the surgical procedure to prepare the bone to receive one or more implants.
  • the CAS system can determine 610 the surgical components by extracting this information from the surgical plan.
  • the CAS system can determine 610 the surgical components based upon a selection of the components by, for example, a surgeon performing the procedure.
  • the CAS system can also determine 615 hole location information related to holes to be drilled into a patient's bone for mounting, for example, a cut guide to the patient's bone.
  • the CAS system can track 620 the position, orientation, and alignment of a drilling device, such as rotating tool 214 as described above, to determine whether the drilling device is properly positioned to cut the determined holes. If the CAS system determines 625 that the drilling tool is in the proper position, the CAS system can initiate operation 630 of the drilling device. If the CAS system does not determine 625 that the drilling device is in the proper position, the CAS system can continue to track 620 the position of the drilling device.
  • the CAS system can monitor the depth of the hole to determine 635 whether the hole is complete. If the hole is complete, the CAS system can stop the operation of the drilling device and either retract the drilling device from the hole or instruct the physician to remove the drilling device (or drilling device tip) from the hole.
  • the CAS system can determine 625 whether the drilling device is still in the proper position during the drilling. If the CAS system does determine 625 the drilling device is in the proper position, the CAS system can continue operation 630 of the drilling device. If the drilling device is no longer in the proper position, the CAS system can continue to track 620 the position of the drilling device.
  • the process as shown in FIG. 9 is shown by way of example only and has been simplified for explanatory purposes.
  • the CAS system can continually track the movement and position of the drilling device during operation and can stop operation of the drilling device at any point when the position or alignment of the drilling device is improper.
  • the CAS system can adjust the position of the tip of the drilling device as described above to properly position and align the drilling device for drilling the hole(s) in the target bone.
  • the techniques and processes as described herein can be implemented within a navigation system that can correlate a planned implant location relative to the bone with a database that contains the necessary pin trajectories associated with each cutting block.
  • Such systems can utilize a surgical plan and coordinate transforms to define where the cut block design aligns with the necessary cuts for the implant.
  • Such systems can determine where the pin trajectories lie within in the cut block, which can be used to determine the proper placement of the pilot holes without the need for manual alignment.
  • the disclosed invention can be used with such a surgical navigation system to precisely align cutting blocks without the need to utilize a jig that is placed with trackers or couplers to eliminate an unnecessary step in conventional robot-assisted implant surgical procedures.
  • the invention can allow for the easy alignment of cutting jigs or guides.
  • the cutting jigs or guides can be smaller or less intricate because they do not have to interface with manual instrumentation sets.
  • the use of smaller or less intricate cutting jigs or guides reduces costs and allows for the use of a single system for alignment of multiple types of jigs or guides to support multiple surgeries and implant designs.
  • compositions, methods, and devices are described in terms of “comprising” various components or steps (interpreted as meaning “including, but not limited to”), the compositions, methods, and devices can also “consist essentially of or “consist of the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups. It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present.

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Abstract

La présente invention concerne un système, un dispositif et un procédé de régulation du fonctionnement d'un outil chirurgical (214) pendant une intervention chirurgicale. Par exemple, le système comprend un ensemble (210) d'outils et un système chirurgical (100). L'ensemble d'outils comprend un outil rotatif (214) et un manchon (212) permettant de retenir l'outil rotatif. Le système chirurgical comprend un système de navigation (200) configuré pour suivre au moins une partie de l'outil rotatif et déterminer des informations de position destinées à l'outil rotatif, un module d'alignement (222) configuré pour recevoir les informations de position et déterminer si l'outil rotatif se trouve dans une position appropriée pour percer un trou dans un os cible (240), un composant de commande robotique (220) configuré pour actionner et faire avancer l'outil rotatif si l'outil rotatif se trouve dans la position appropriée, et un moniteur (226) configuré pour déterminer si l'outil rotatif avance dans l'os cible le long d'un trajet prédéfini.
PCT/US2018/013892 2017-01-16 2018-01-16 Outil chirurgical suivi à extension régulée WO2018132835A1 (fr)

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US16/751,911 US20200155175A1 (en) 2017-01-16 2020-01-24 Tracked surgical tool with controlled extension

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